lung cancer
Conditions
Interventions
Experimental group:QL1706 plus bevacizumab and chemotherapy
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form before any trial-related procedures; 2. Age >=18 and = 3 months; 10. Prior to the first administration, any adverse events (AEs) related to previous anti-tumor therapy had recovered (i.e., =1.5×10^9/L; (2) Platelet count >= 100 × 10^9/L; (3) Hemoglobin >= 90 g/L; (4) Serum albumin >=30 g/L; (5)AST and ALT =50 mL/min; Proteinuria = 2+, a 24-hour urine protein quantification should be performed; eligibility is granted if <=1g); (8)International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) <=1.5 × Upper Limit of Normal (ULN); 12. Fertile female subjects must undergo a urine or serum pregnancy test (if the urine pregnancy test result cannot confirm a negative outcome, a serum pregnancy test must be performed, with the serum pregnancy result taking precedence) within 7 days before the first dose of medication, and the result must be negative. If a fertile female subject engages in sexual activity with a non-sterilized male partner, she must adopt an acceptable contraceptive method from the screening phase onward and agree to continue using contraception for 120 days after the last dose of the study drug. Whether to discontinue contraception beyond this period should be discussed with the investigator;
Exclusion criteria
Exclusion criteria: 1.Patients who have undergone other systemic anti-tumor treatments after progression to third-generation EGFR-TKI resistance; 2. Prior treatment with anti-PD-1, anti-PD-L1, or any other immunotherapy (e.g., anti-CTLA-4, anti-CD137, etc.); 3. Received anticoagulant therapy (excluding low molecular weight heparin treatment) within 2 weeks prior to the first dose administration; 4. Occurrence of systemic infection or other severe infections within 2 weeks before the first dose; 5. Received systemic steroid therapy or any other form of immunosuppressive treatment within 7 days prior to the first administration of the investigational drug; 6. Symptomatic central nervous system (CNS) metastasis; 7. Presence of concomitant diseases or conditions that may increase the risk of adverse events during the study period, such as: uncontrolled hypertension despite standard treatment; history of hypertensive crisis or hypertensive encephalopathy; history of intracranial or spinal cord hemorrhage; current evidence of bleeding tendency or severe coagulopathy or tumors involving major blood vessels; 8. Patients who have experienced hemoptysis or a history of gastrointestinal bleeding within one month before the first dose and are deemed ineligible for enrollment by the investigator; 9. Individuals with a history and/or current interstitial lung disease, pneumoconiosis, radiation pneumonitis, or severe pulmonary impairment; 10. HIV-positive; hepatitis B-positive; tuberculosis-positive; active syphilis infection; 11. Subjects with a history of other malignant tumors within 5 years prior to signing the informed consent (excluding cured basal cell skin cancer, papillary thyroid carcinoma, etc.); 12. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (excluding corneal transplantation); 13. Having received a live vaccine within 4 weeks prior to the first administration of the drug; 14. Participants who had participated in other clinical studies and used other investigational drugs within 4 weeks prior to the first dose administration; 15. Subjects deemed unsuitable for enrollment by the researchers, such as those who may pose increased risks related to the study or could potentially interfere with the interpretation of research findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS;Disease Control Rate,DCR;Adverse Events,AE;Overall Survival,OS; | — |
Countries
China
Contacts
Public ContactWang Guowen
The First Affiliated Hospital of Bengbu Medical University, Bengbu City, Anhui Province
Outcome results
None listed